Drug delivery devices for setting and dispensing a single or multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe.
Drug delivery devices, in particular pen-type injectors have to meet a number of user-specific requirements. For instance, with patient's suffering chronic diseases, such like diabetes, the patient may be physically infirm and may also have impaired vision. Suitable drug delivery devices especially intended for home medication therefore need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and easy understandable. Moreover, a dose setting as well as a dose dispensing procedure must be easy to operate and has to be unambiguous.
For instance, such devices comprise a housing to receive a cartridge being at least partially filled with the medicament to be dispensed. The device further comprises a drive mechanism, typically having a displaceable piston rod to operably engage with a piston of the cartridge. By means of the drive mechanism and its piston rod, the piston of the cartridge can be displaced in a distal or dispensing direction and may therefore expel a pre-defined amount of the medicament via a piercing assembly which is to be releasably coupled with a distal or dispensing end of the housing of the drug delivery device.
Drug delivery devices, such as pen-type injectors are commonly manufactured in large quantities by way of an assembly line in a mass production environment. Especially with pen-type injectors but also with other drug delivery devices, the primary packaging containing and providing the medicament can be readily provided with a dispensing mechanism. The device may be designed as a disposable device, which after use or consumption of the medicament is to be discarded. For safety reasons, charges or batches of drug delivery devices, especially those having a medicament containing cartridge readily disposed therein, have to be unequivocally retraceable even after the drug delivery device and the medicament therein have been distributed across various trade channels.
Retraceability of medicaments and/or drug delivery devices associated therewith imposes a respective burden on the manufacturer. If for instance a medicament or a device belonging to a particular charge exhibits a malfunction or some other kind of defect, all further entities of the respective charge should not enter the market or have to be fetched back.
There exist various approaches to individually assign single entities of primary packagings of liquid medicaments. For instance, WO 20011/032956 A2 discloses a stopper for sealing a compartment of a medicament container, wherein a microchip comprising at least one sensor is embedded into said stopper. The microchip is arranged for storing data comprising measurement data acquired by the sensor and the microchip further comprises wireless communication means for allowing the stored data to be retrieved by an external wireless unit. This for instance allows to provide the medicament container with an ID upon manufacturing in order to make it tamper-proof. Moreover, data may be stored into the microchip upon production via the wireless communication. The data may comprise time stamps for each manufacturing step in order to be able to retrace the production chain and/or the whole life cycle of the cartridge.
Individual labelling of single units of medicament containers or drug delivery devices requires to handle such data appropriately. Since hundreds of thousands or even millions of medicament containers are for instance to be produced in only a months time, a tremendous amount of data will be generated that has to be appropriately handled and stored over a comparatively long time interval. Moreover, by treating and handling any device component individually, a rather sophisticated and complicated logistic concept is required in general.
It is therefore one object of the present invention to provide a new concept of manufacturing medical devices, especially drug delivery devices equipped with a medicament containing cartridge, wherein product related data can be used in a more efficient way. Moreover, it is a further object, to provide improved control and release mechanisms in an assembly line for assembling drug delivery devices. Additionally, a new and beneficial logistic concept is to be achieved making use of individually labelling selected device components by simultaneously reducing the amount of data to be stored and handled by the device manufacturer.